Pylarify is a drug owned by Progenics Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2021 to 2024 out of which none have expired yet. Pylarify's patents will be open to challenges from 26 May, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 09, 2037. Details of Pylarify's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US10947197 | Synthesis of the radiolabeled prostate-specific membrane antigen (PSMA) inhibitor [18F]DCFPyL |
Jun, 2037
(12 years from now) | Active |
| US11851407 | Synthesis of the radiolabeled prostate-specific membrane antigen (PSMA) inhibitor [18F]DCFPYL |
Jun, 2037
(12 years from now) | Active |
| US8778305 | PSMA-binding agents and uses thereof |
Sep, 2030
(5 years from now) | Active |
| US9861713 | PSMA-binding agents and uses thereof |
Jul, 2029
(4 years from now) | Active |
| US8487129 | Heterodimers of glutamic acid |
Nov, 2027
(2 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Pylarify's patents.
Latest Legal Activities on Pylarify's Patents
Given below is the list of recent legal activities going on the following patents of Pylarify.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation Critical | 26 Dec, 2023 | US11851407 |
| Email Notification Critical | 26 Dec, 2023 | US11851407 |
| Recordation of Patent eGrant | 26 Dec, 2023 | US11851407 |
| Recordation of Patent Grant Mailed Critical | 26 Dec, 2023 | US11851407 |
| Patent eGrant Notification | 26 Dec, 2023 | US11851407 |
| Mail Patent eGrant Notification | 26 Dec, 2023 | US11851407 |
| Email Notification Critical | 07 Dec, 2023 | US11851407 |
| Issue Notification Mailed Critical | 06 Dec, 2023 | US11851407 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US8487129 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US8778305 |
FDA has granted several exclusivities to Pylarify. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pylarify, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Pylarify.
Exclusivity Information
Pylarify holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Pylarify's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 26, 2026 |
Several oppositions have been filed on Pylarify's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Pylarify's generic, the next section provides detailed information on ongoing and past EP oppositions related to Pylarify patents.
Pylarify's Oppositions Filed in EPO
Pylarify has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 23, 2021, by Lewis Silkin Llp. This opposition was filed on patent number EP18150494A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP19214298A | Jan, 2023 | Telix Innovations S.A. | Granted and Under Opposition |
| EP18150494A | Sep, 2021 | Deutsches Krebsforschungszentrum - Stiftung des öffentlichen Rechts / Universität Heidelberg | Revoked |
| EP18150494A | Sep, 2021 | POLSERVICE KANCELARIA RZECZNIKOW PATENTOWYCH SP. Z O.O. | Revoked |
| EP18150494A | Sep, 2021 | Lewis Silkin LLP | Revoked |
US patents provide insights into the exclusivity only within the United States, but Pylarify is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Pylarify's family patents as well as insights into ongoing legal events on those patents.
Pylarify's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pylarify's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 09, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pylarify Generics:
There are no approved generic versions for Pylarify as of now.
About Pylarify
Pylarify is a drug owned by Progenics Pharmaceuticals Inc. It is used for imaging and diagnosis of prostate cancer in men through PET scans. Pylarify uses Piflufolastat F-18 as an active ingredient. Pylarify was launched by Progenics Pharms Inc in 2021.
Can you believe Pylarify received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Pylarify was approved by FDA for market use on 26 May, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Pylarify is 26 May, 2021, its NCE-1 date is estimated to be 26 May, 2025.
Active Ingredient:
Pylarify uses Piflufolastat F-18 as the active ingredient. Check out other Drugs and Companies using Piflufolastat F-18 ingredient
Treatment:
Pylarify is used for imaging and diagnosis of prostate cancer in men through PET scans.
Dosage:
Pylarify is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50ML (1-80mCi/ML) | SOLUTION | Prescription | INTRAVENOUS |